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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025454
Receipt No. R000029291
Scientific Title The effect of SGLT2 inhibitor tofogliflozin on glycemic daily variation by blood glucose using CGMs in patient with type 2 diabetes.
Date of disclosure of the study information 2016/12/28
Last modified on 2016/12/28

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Basic information
Public title The effect of SGLT2 inhibitor tofogliflozin on glycemic daily variation by blood glucose using CGMs in patient with type 2 diabetes.
Acronym The effect of SGLT2 inhibitor tofogliflozin on glycemic daily variation by blood glucose using CGMs in patient with type 2 diabetes.
Scientific Title The effect of SGLT2 inhibitor tofogliflozin on glycemic daily variation by blood glucose using CGMs in patient with type 2 diabetes.
Scientific Title:Acronym The effect of SGLT2 inhibitor tofogliflozin on glycemic daily variation by blood glucose using CGMs in patient with type 2 diabetes.
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effect of SGLT2 inhibitor tofogliflozin on glycemic daily valiation by blood glucose using CGMs(continuous glucose monitoring) in patient with type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes glycemic daily valiation in blood glucose using CGMs
Key secondary outcomes The change in
1)fasting blood glucose
2)blood pressure
3)Safety evaluation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tofogliflozin group
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 7.0 and 12.4 %) under medical treatment by dieting and exercise cure and/or drug treatment.
2)Over 20 years old and less than 80 years old
3)Sex unquestioned
4)Patients with no history of cardiovascular disease
5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization.
6)The patient who gives a written informed
Key exclusion criteria 1)Type 1 diabetes
2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges)
3)A pregnant woman and/or a woman under breast-feeding
4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women)
5)Diabetic proliferative retinopathy
6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug
7)Cigarette smokers
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshie Iijima
Organization Dokkyo Medical University
Division name Department of Endocrinology and Metabolism
Zip code
Address 880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL 0282-87-2150
Email toshie@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshie Iijma
Organization Dokkyo Medical University
Division name Department of Endocrinology and Metabolism
Zip code
Address 880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL 0282-87-2150
Homepage URL
Email toshie@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Department of Endocrinology and Metabolism
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 28 Day
Last modified on
2016 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029291

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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